PMA P130012S009
- Device
- Myopore® Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S009
- Product code
- DTB
- Decision date
- 2022-10-05
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Implement a revised sterilization parameter for Myopore products in an effort to reduce the EO emission.
Current openFDA PMA Record#
- Device
- Myopore® Sutureless Myocardial Pacing Lead
- Applicant
- Great Batch Medical
- PMA number
- P130012
- Supplement
- S009
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2022-10-05
- Decision code
- OK30
- Date received
- 2022-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a revised sterilization parameter for Myopore products in an effort to reduce the EO emission.